Androgen Ablation With or Without Docetaxel in Treating Patients With Advanced Prostate Cancer

Phase 3

• Conditions: Pain; Prostate Cancer
• Interventions: Drug: releasing hormone agonist therapy; Drug: docetaxel

• Registration Number: NCT00796458
• Lead Sponsor: A.O.U. San Giovanni Battista di Torino, Italy

Brief Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy may lessen the amount of androgens made by the body. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving androgen ablation therapy together with docetaxel is more effective than giving androgen ablation therapy alone in treating patients with advanced prostate cancer.

PURPOSE: This randomized phase III trial is studying androgen ablation and docetaxel to see how well they work compared with androgen ablation alone in treating patients with advanced prostate cancer.

Detailed Description

OBJECTIVES:

Primary

* Compare the 2-year progression-free survival rate (biological progression and/or clinical progression) in patients with advanced prostate cancer treated with androgen ablation with vs without docetaxel.

Secondary

* Compare the overall survival of patients treated with these regimens.

* Compare the time to treatment failure in patients treated with these regimens.

* Compare the toxicity profiles of these regimens in these patients.

* Compare the PSA response rate in patients treated with these regimens.

* Compare the response rate in patients with measurable disease treated with these regimens.

* Compare the percentage of patients who undergo PSA normalization.

* Compare the quality of life of patients treated with these regimens.

* Compare the efficacy of these regimens in controlling bone pain in these patients.

* Compare the changes in chromogranin A levels in patients treated with these regimens.

* Compare the total cost of care of patients treated with these regimens.

OUTLINE: This is a multicenter study.

Patients receive luteinizing hormone-releasing hormone analogue (LHRH-A) therapy for 6 months. Patients also receive antiandrogen therapy during the first 5 weeks of LHRH-A therapy. After 6 months of LHRH-A therapy, patients with PSA response are randomized to 1 of 2 treatment arms.

* Arm I: Patients continue to receive LHRH-A therapy until disease progression.

* Arm II:Patients receive LHRH-A therapy as in arm I. Patients also receive docetaxel IV on day 1. Treatment with docetaxel repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Patients complete questionnaires during treatment to assess bone pain. Quality of life is also assessed.

After completion to study therapy, patients are followed for ≥ 2 years.

Study Timeline

• Study Start: 2005-04
• Status Verified: 2008-11
• Study First Submitted: 2008-11-21
• Study First Submitted QC: 2008-11-21
• Study First Posted: 2008-11-24
• Last Update Submitted: 2013-08-09
• Last Update Posted: 2013-08-12
• Primary Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 200

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm I	releasing hormone agonist therapy	Patients continue to receive LHRH-A therapy until disease progression.
Arm II	releasing hormone agonist therapy	Patients receive LHRH-A therapy as in arm I. Patients also receive docetaxel IV on day 1. Treatment with docetaxel repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Arm II	docetaxel	Patients receive LHRH-A therapy as in arm I. Patients also receive docetaxel IV on day 1. Treatment with docetaxel repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
2-year progression-free survival rate

Secondary Outcome Measures

Name	Time	Method
Overall survival
Time to treatment failure
Toxicity as assessed by NCI CTCAE criteria
PSA response rate (> 50% reduction from baseline)
Disease response rate as assessed by RECIST criteria (in patients with measurable disease)
PSA normalization (normal range 0-4 ng/mL)
Quality of life
Efficacy of treatment in controlling bone pain
Changes in chromogranin A levels
Cost analysis

Trial Locations

Locations (1)

Rete Oncologica Piemontese - Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino; 🇮🇹 Turin, Italy